Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations
Advanced stage lung cancer is generally treated with anti-cancer medication called chemotherapy. Most lung cancer is caused by cigarette smoking. However, some lung cancers develop in people who never smoked or who only smoked for a short period of time. This type of lung cancer may respond to a medication called erlotinib (Tarceva). Erlotinib is an anticancer pill that is approved by the Food and Drug Administration (FDA) for use in patients with advanced lung cancer. Unfortunately, erlotinib does not work for all patients or only works for a period of time. The doctors are trying to find ways to improve the effect of erlotinib by combining it with another anti-cancer medication.
Ascenta Therapeutics, Inc. has developed a drug called AT-101 as a potential treatment for cancer. AT-101 is an investigational drug. That means that AT-101 is not approved by the United States Food and Drug Administration (FDA) for general use. The FDA does permit its use in studies like this one to determine whether it is safe and effective.
This is the first study to examine the effects of AT-101 and erlotinib. It is hoped that by combining AT-101 with erlotinib, AT-101 may help erlotinib work better to shrink lung cancer. Studies that have been performed in the laboratory suggest that AT-101 in combination with erlotinib may be more effective at shrinking tumors than erlotinib alone.
|Lung Cancer||Drug: oral erlotinib and pulsed doses of oral AT-101||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Activating Mutations|
- Radiographic Objective Response Rate [ Time Frame: 21 days after cycle one ](CR+PR, by WHO Criteria for Standard Bidimensional Tumor Measurement) After One 21-day Cycle of Combination Therapy With Erlotinib and AT-101
|Study Start Date:||September 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: oral erlotinib and pulsed doses of oral AT-101
This will be an open-label, single institution, phase II trial. The study will assess the efficacy of the combination of the epidermal growth factor receptor tyrosine kinase inhibitor, erlotinib, and the novel pan-Bcl-2 inhibitor, AT-101, in treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations A planned pause of 21 days will be performed after enrollment of the 10th and 20th patient to assess for excessive toxicity.
Drug: oral erlotinib and pulsed doses of oral AT-101
Patients will receive oral erlotinib 100 mg daily and pulsed doses of oral AT-101 given 40 mg twice daily on days 1-3 of a 21-day cycle. If the initial combination of erlotinib and AT-101 is tolerated, dose escalation of erlotinib to 150 mg daily will be allowed at the discretion of the treating investigator at the start of cycle 2. Patients will continue receiving treatment on study until they refuse further therapy, develop evidence of progressive disease, or develop unacceptable toxicity or a medical condition that would, in the judgment of the investigator,
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988169
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Naiyer Rizvi, MD||Memorial Sloan Kettering Cancer Center|